Clinical Development Services
As a trusted partner in your development operations, Actalent aims to be your preferred vendor for your embedded and outsourced needs. We provide solutions to your shifting business needs and priorities.
Actalent partners with life sciences companies to drive regulated product development through our comprehensive Functional Service Provider (FSP) offerings.
Our FSP managed services enables life sciences organisations to scale and supplement core functions while outsourcing non-core functions throughout the product life cycle of a drug, device, diagnostic or combination products. We deliver high-quality work that seamlessly integrates with your current operations, using either your internal tools, systems and procedures or leveraging Actalent's ICH-GCP compliant tools, systems and procedures.
Who We Are
Founded in 1981 and headquartered in Maryland, we are a global FSP clinical development services organization.
Recognized as the largest clinical talent services provider in the U.S. for multiple years, we have four global FSP delivery centers.
Our team possesses deep technical expertise, combining digital solutions with genuine experience in clinical development, regulatory and quality, medical safety and the end-to-end product development life cycle.
Our Solutions
- Clinical trial management
- Regulatory affairs
- Data sciences
- Quality and compliance
- Medical affairs
- Site services
Our Services
We don’t just support your trials—we help you deliver results faster, with greater confidence.
Through our flexible FSP model, we give you the ability to scale quickly while maintaining full control and visibility.
Our global clinical operations teams—CPMs, CRAs, and study start-up specialists—are active across the globe, ensuring rapid site activation, strong investigator engagement and reliable patient recruitment performance.
In data sciences, our multidisciplinary team of data engineers, EDC developers, data managers, biostatisticians and programmers transforms your data into a competitive advantage. From scalable data architecture to accelerated data cleaning, advanced analytics and real-time insights, we enable faster, smarter decision-making at every stage of your trial.
Our regulatory affairs, and quality and compliance specialists proactively navigate complex global requirements, helping you stay inspection-ready, reduce delays and bring therapies to market with confidence.
FSP Delivery Models
Project-Based
For clients requiring functional resourcing support on projects with clearly defined milestones, timelines and deliverables, we provide tailored project-based solutions to meet your specific requirements.
Full Functional Outsourcing
For clients requiring ongoing functional resourcing support, we create and manage dedicated functional teams (e.g., monitoring, data management).
Hybrid-Based
For clients requiring supplemental resourcing within a function, we provide resources who you directly manage the day-to-day operational tasks for, while Actalent handles the line management of those resources.
Our Expertise in Clinical Development Services
- Monitoring and site management
- Study start-up support
- Vendor selection and management
- Ethics submission
- Investigator initiated study management
- Site coordination and administration
- TMF management
- Technical writing
- Preparation of regulatory dossier and submission
- PV reporting
- Regulatory compliance
- Investigational clinical trials submission support
- CTA/IITA
- IND/IDE
Data engineering
- ETL/ELT pipelines
- Snowflake
- Data lakes
- Analytics platforms
EDC developers
- eCRFs
- Edit checks
Data management
- DMP/DVP/DRP
- Data cleaning
- Coding
Biometrics
- Statistical consulting
- SAPs
- Randomization
- Submission ready datasets (SDTM and ADaM)
- IA and DMCs
- Safety data review
- TLFs
- Statistical reports
Visualization
- Spotfire
- Tableau BI
- R-Shiny
Real-world evidence
Digital solutions (web application – R-Shiny and AI/LLM Agents)
- QMS development and remediation
- GxP auditing and inspection readiness
- CAPA, deviations and RBQM
- TMF/eTMF oversight
- Vendor qualification and oversight
- Clinical quality operations
- Training, SOPs and document control
- CSV/CSA validation support
- Medical writing
- Protocol development
- Clinical study report narrative
- Publication and manuscript
- Pharmacovigilance and drug safety
- Medical monitoring
- Safety assessment
- Real world evidence
- Site protocol champion
- Training and continuous improvement initiatives
- Informed consent writing/review
- Patient recruitment planning
- Data entry/review
- Query management
- CRA visit support
- Clinical document management
- Site budget and contract negotiation
- Regulatory support
Problems We've Solved
Actalent supports life sciences clients with varying sizes, footprints and market shares, including some of the most recognisable companies in the world. Through these successful partnerships, we've developed solutions that have supported:
- Clinical and regulatory gap assessment and support
- Global clinical operations study execution and monitoring
- Regulatory dossier writing and submission
- Rescue clinical trial support and data sciences support
- Data management systems validation and training
- Innovate web applications and AI through digital solutions
- Internal and external GxP auditing
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Case Study
Actalent Helps Client Maintain $20 Million of its Market Share by Securing Approval of its EU Product LinesLeader in Sports Medicine and Rehab Products Successfully Navigates Strict New EU Medical Device Regulations (MDR)
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Article
Aggregating Data Sources - Enhancing Clinical Trial ResultsWhile data gained through clinical trials is significant at the individual trial level, its value increases exponentially when the information is proactively aggregated, shared, cleansed and analyzed.
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Article
Assessing CRA Monitoring Performance in a Digital WorldHow does your company assess the performance of clinical research associates to ensure quality and safety standards are consistently upheld?
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Delivery Centers
With unmatched expertise and knowledge, access to top-tier talent, technical resources and an expansive vendor network, our clinical development services can be delivered through a combination of on-site/embedded, hybrid, remote, near-shore and off-shore locations. Our FSP delivery centers are located in the following areas:
Quality Assurance and Privacy
Quality. Integrity. Trust.
Actalent strives to deliver on time, on budget and on schedule every day.
We know how hard it is to select the right FSP vendor for your product development needs. This is why we work hard from the beginning all the way to the end of our FSP programs to keep your trust and confidence in our service offerings. Actalent is with you every step of the way.
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